An observational study in Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder and Malignant Solid Neoplasm, sponsored by Alliance for Clinical Trials in Oncology. Recruiting at 630 sites in United States. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Alliance for Clinical Trials in Oncology · Observational
This study collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
PRIMARY OBJECTIVES:
To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).
OUTLINE:
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 96 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for 1 year.
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 2,240 is above the median of 186 across 322 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have received one or more immuno-oncology therapeutics and experienced one or more serious adverse events (AEs)
REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics
REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:
One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in (CTCAE) version (v.) 5.0 that may be immune-related
** Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded
Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
** Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.
Procedure: Biospecimen Collection · Other: Medical Chart Review
Undergo collection of tissue, blood, and stool samples
Review of medical records
Establishment of a national biorepository including biospecimen and clinical data collections for future use
The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.
Time frame: Up to 1 year
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Showing the first 100 of 630 sites. Choose a country and city above to see the rest.
Started Mar 2020 (actual). Primary completion is estimated for Oct 2027, 90 months after the start.
Of 164 non-industry observational studies under Hematologic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 322. This study's planned 90 months is above that.
Counting every sponsor, half of 186 studies reached it within 74 months; a quarter within 34 and three quarters within 322.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Oct 2026 → Oct 2027 and completion Oct 2026 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Alliance for Clinical Trials in Oncology →